News
Master Service Agreement for ISM-001
First work program initiated August 2024
Strategic collaboration encompassing initial process development through to clinical trial supply
IsomAb Ltd, a UK-based biotechnology company developing developing isoform-specific, disease modifying antibody treatments for serious and life-threatening diseases, today announced it has entered into a strategic collaboration with Catalent, Inc.; the leader in enabling the development and supply of better treatments for patients worldwide. The Master Service Agreement encompasses development of ISM-001 from cell line development through to finished clinical trial product supply; work will be performed in the USA and the EU. IsomAb will retain ongoing decision-making autonomy and full rights to the program throughout the collaboration.
ISM-001 is a first-in-class, therapeutic antibody designed to neutralise the anti-angiogenic VEGF-A splice isoform VEGF-A165b; the first target patient group are those with type 2 diabetes and peripheral artery disease with symptoms of chronic limb-threatening ischemia. ISM-001 has been nominated as the Development Candidate and is being advanced into a program of pre-clinical studies necessary for gaining approval to enter first-in-human clinical trials.
More than 230 million people worldwide are living with PAD; key risk factors for developing the disease are type 2 diabetes, obesity, high blood pressure and high cholesterol levels. CLTI develops in patients due to lack of resources in primary care and of effective treatments, which results in a high risk of amputation; this has been estimated at 25% at one year1.
Jackie Turnbull, CEO of IsomAb Ltd, said: “We look forward to working with Catalent, a leading CDMO with premier capabilities in biologics development and manufacturing, on the development of ISM-001. This partnership demonstrates our commitment to a robust manufacturing process that will move our therapeutic program into the clinic as quickly as possible. Catalent’s expertise at integrating end-to-end services through their OneBio® offering was a significant factor in our decision to partner with Catalent as we plan for future development of ISM-001.”
David McErlane, Group President of Biologics said: “Catalent is committed to partnering early in the development process with innovative companies like IsomAb. We are excited to work together to develop ISM-001 and are committed to the development and manufacturing of safe, high-quality biologic therapies to provide breakthrough treatment to patients.”
1 Eur J Vasc Endovasc Surg (2020) 60, 643 – 644